Image is Everything: MRI and Helium Safety

 

MRI

Magnetic resonance imaging (MRI) is a diagnostic procedure that uses a combination of a very large magnet, radio waves, and a computer to produce detailed, cross-sectional, and three-dimensional images of organs and structures within the body.

An MRI scan is a valuable diagnostic tool that can show injuries or other anomalies that cannot be seen in a CT scan or X-ray.  For instance, soft tissue injuries, such as,strains, sprains, contusions, tendonitis, and bursitis can all be observed via MRI.

Moreover, according to the Mayo Clinic, MRI can also be used to diagnose a variety of brain-related and nervous system disorders, including strokes, aneurysms, multiple sclerosis, eye and inner ear problems, and spinal cord injuries. MRI is widely used in research on brain structures and functions.

How MRI Works

MRI scanning machines vary in size, shape, and degree of openness but the typical MRI machine resembles a tube (encompassing a very large magnet) with a table in the middle, which enables the patient to lie down and slide into the magnetic field created inside the machine. The magnet itself is comprised of multiple coils of connective wire through which a current is passed to generate a magnetic field. To achieve the high field strengths required for most clinical needs, the magnet is cooled with liquid helium to -452 degrees Fahrenheit (-270 Celsius). The super cold temperature applied to the magnet provides for “superconductivity”, meaning that current can pass through the magnet’s coils without electrical resistance, producing the type of strong magnetic field necessary to produce detailed images.

To ensure accurate imaging, and to preserve the integrity of the MRI scanning machine, the liquid helium must be kept extremely cold when the scanner is in operation. If the temperature of the liquid helium were to rise above the very cold levels required for superconductivity, the helium might vaporize and,with the dissipation of the liquid helium’s super-cooling properties,  the machine’s magnet could overheat, potentially causing irreparable damage to the MRI machine.

Oxygen Monitors Can Detect Helium Leaks

Helium is an odorless, colorless, oxygen-depleting gas that can rapidly displace oxygen in the air to levels below what is needed to for humans to breathe. Excess exposure to helium can cause dizziness, nausea, and loss of consciousness, and could even result in death within seconds of exposure. Because liquid helium is devoid of color and odor, MRI personnel would, absent appropriate oxygen monitoring, likely be unaware that a potentially dangerous helium leak has occurred. As such, the National Institutes of Health’s Design Requirements Manual recommends that oxygen monitors be installed in MRI treatment areas.

Proper oxygen monitoring equipment should be placed in MRI rooms, as well as in storage rooms, and in any other site where helium gas may accumulate. The monitoring equipment should include visual and audible alarms that would be activated in the event of helium leaks and a decrease in oxygen levels.

PureAire Oxygen Deficiency Monitors

PureAire Monitoring Systems’ Sample Draw Oxygen Deficiency Monitor continuously tracks levels of oxygen and will detect helium leaks before MRI machines are damaged and the health of employees and patients is put at risk.

The Monitor’s built-in pump samples oxygen from up to 100 feet away,making it ideal for use in MRI facilities, because the metal components within the Monitor are outside the imaging area and, therefore, will not interfere with the magnets that are the heart of MRI scanning machines.

PureAire’s durable, non-depleting, zirconium oxide sensor can last 10+ years in a normal environment, without needing to be replaced.

In the event of a helium gas leak, and a decrease in oxygen to an unsafe, OSHA action level, the Sample Draw Oxygen Monitor will set off an alarm, complete with horns and flashing lights, alerting staff and patients to evacuate the area. Additionally, the same alarm will alert personnel to turn off the MRI scanner in order to prevent the magnet overheating that could result in possible damage to the machine.

PureAire’s Sample Draw Oxygen Deficiency Monitor has an easy to read screen, which displays current oxygen levels, for at-a-glance observation by MRI employees, who derive peace of mind from the Monitor’s presence and reliability.

What Are Hot Melt Adhesives? Why Are They Used and What Is the Importance Of Nitrogen Gas?

 Hot Melt Adhesives and Available Types Used in Industrial Manufacturing

Industrial hot melt adhesives are polymer-based thermoplastic resins that, when melted, are used to bond materials together. Hot melt adhesives are comprised of one or more base polymers combined with tackifiers (which provide stickiness to the adhesive), plasticizers (to provide greater flexibility), and antioxidants (for protection against degradation) to allow for stability, adhesion, and flexibility.

Industrial hot melt is available in a variety of forms, including granular or powder hot melt blocks, pellets, bags, cakes, drums, and pillows. These materials are solid at room temperature, and then heated, melted, and dispensed for a variety of industrial applications.  As the adhesive returns to room temperature, a strong bond is created, adhering the manufacturing components together.

Hot melt can be dispensed as a liquid or, by introducing an inert gas (such as nitrogen) to the hot melt, as a foam.

Industrial Hot Melt Applications

In either liquid or foam form, hot melt adhesive is used across a wide variety of industries including  aerospace; automotive; product assembly; furniture making, cabinetry, and upholstery; product packaging; book binding; and non-woven sanitary hygiene products.

Aerospace and automobile manufacturers utilize hot melt adhesives for potting electronics (a process used to protect sensitive components from impact or vibration), as well as sealing rivets, seams, and joints. Additionally, hot melt foam is used in airplanes and cars as insulation around doors and windows to reduce vibrations and noise, as well as in seat assembly.

The pages in books and magazines are kept securely bound together using HMAs. The packaging industry depends on a strong adhesive bond to keep the flaps of corrugated boxes and cartons securely closed.

Non-woven personal hygiene products are manufactured by utilizing hot melt adhesives throughout the manufacturing process, including adhering the elastic strands in the leg openings and waistbands, bonding the fabric layers together to secure and stabilize the wetness core, and affixing the fastening tapes to the waistband.

Charring

Charring is akey concern when working with hot melt adhesives, as char (degraded adhesives that have oxidized, hardened into a gel, and been blackened and burned) can negatively affect the adhesives, cause equipment failure, and lead to a shut-down in production.

Key causes of charring include overheating (typically as a result of either using a temperature that is too high for a particular hotmelt, excessive heating times, or incorrect melt tank size); oxidation (exposing the adhesives to too much oxygen), and contamination (from dirt, dust and other materials that fall into the hotmelt and burn).

Once formed, the char can break off into pieces that may clog filters and stop up spray and bead nozzles. The pieces of char can work their way onto the materials to be bonded, leaving marks, streaks, and uneven surfaces. Eventually, bits of char may get into hoses and pumps, breaking seals and scoring and damaging hoses and pump walls.

Why Nitrogen is Used for Hot Melt Adhesive

To reduce potential damage from charring, hotmelt operators may elect to blanket the adhesives with nitrogen (N2) in a process by which nitrogen, an oxygen depleting gas, is piped into the space between the hotmelt adhesive and the top of the hopper or melt tank. The nitrogen blanket protects the adhesive by creating a barrier against falling debris, and it also removes oxygen and moisture which may cause the hotmelt to oxidize and form char .

Oxygen Monitors Improves Quality Control and Helps Protect Employees

To preserve the integrity of the hot melt while blanketing with nitrogen, employees must maintain proper oxygen levels within hoppers or melt tanks, as too much oxygen can cause oxidation. Proper oxygen monitoring equipment should be placed inside melt tanks to measure and control oxygen levels.  A nitrogen leak could lead to failure of the nitrogen blanket, which could compromise the integrity of the adhesives.

Moreover, wherever nitrogen is used, the possibility of nitrogen leaks poses potential risks to humans. Since nitrogen displaces oxygen, a leak could deprive the air of oxygen, thereby creating a possible health hazard for personnel. When there is not enough oxygen in the air, persons working in the area can become disoriented, lose consciousness, or even suffocate due to the lack of oxygen. Since nitrogen lacks color and odor, there is no way, absent appropriate monitoring, for employees to detect a leak.

Best practice calls for oxygen deficiency monitors to be installed anywhere there is a risk of gas leaks. As such, oxygen monitors should be placed wherever nitrogen is stored, and in all areas where nitrogen is used.

PureAire O2 Deficiency Monitors

PureAire Monitoring Systems’ line of Oxygen Deficiency Monitors and Water Resistant Sample Draw Oxygen Monitors continuously track levels of oxygen and will alert hotmelt personnel to nitrogen leaks before employees’ health is put at risk.  In the event of a nitrogen gas leak, and a decrease in oxygen to an unsafe level, the monitor will set off an alarm, complete with horns and flashing lights, alerting employees to evacuate the area.

PureAire’s Water Resistant Sample Draw Oxygen Monitor is a self-contained oxygen deficiency system that is suitable for remote sampling of oxygen levels in confined spaces, hotmelt tanks, and other locations where remote oxygen monitoring is required. The built-in pump samples oxygen levels from up to 100 feet away.

PureAire oxygen monitors measure oxygen 24/7, with no time-consuming maintenance or calibration required. Built with zirconium oxide sensor cells to ensure longevity, PureAire’s O2 monitors can last, trouble-free, for over 10 years under normal operating conditions.Each PureAire O2 monitor has an easy to read screen, which displays current oxygen levels, for at-a-glance readings by hotmelt manufacturers, who derive peace of mind from the monitor’s presence and reliability.

Pharmaceutical Companies Rely on Nitrogen

Pharmaceutical firms research, develop, and manufacture over-the-counter and prescription drugs and medicines. Usage of these drugs includes, but is not limited to, vaccinations, treatment for chronic conditions, and pain management.

To protect the health and well-being of the public, the pharmaceutical industry is one of the most highly regulated industries. For instance, in the United States, the Food and Drug Administration (FDA) carefully monitors pharmaceutical companies to ensure they are complying with the FDA’s Current Good Manufacturing Practice regulations. These regulations contain requirements for the methods, facilities, and controls used in manufacturing, processing, and packaging of a drug product.  The regulations are intended to ensure that a product is safe for use, and that it contains the ingredients and strengths it claims to have.

Pharmaceutical Manufacturers Rely on Nitrogen

Pharmaceutical manufacturers rely on nitrogen(N2) (an abundant, inert gas which makes up 78% of the air we breathe) for a wide range of uses, including everything from mixing raw materials, to cryogenic grinding (a process using liquid nitrogen to create ultra-fine, uniform particles), to purging oxygen from packaging.

A sterile environment is critical throughout the drug manufacturing and packaging processes. Nitrogen is used to remove oxygen (O2), moisture, and other possible contaminants,in order to create and maintain a sterile environment for production and packaging.

Nitrogen blanketing is the process by which pharmaceutical manufacturers create an inert, non-reactive, environment for safely mixing chemical compounds. Blanketing with nitrogen safeguards against corrosion and oxidation, and prevents possible volatile reactions that might occur if O2 were present, as  some medicinal compounds can be highly combustible when exposed to oxygen.

Oxygen and moisture are purged from packaging not only to maintain sterility but also to protect products during transport, and prolong the stability and shelf life of the packaged drugs.

Oxygen Monitors Can Reduce Risk in Pharmaceutical Manufacturing Facilities Utilizing Nitrogen

Nitrogen is an oxygen-depleting gas that is both odorless and colorless. As such, absent appropriate monitoring, workers would be unable to detect a nitrogen leak if one were to occur in a gas cylinder or line. When there is not enough oxygen in the air, persons working in the area can become disoriented, lose consciousness, or even suffocate due to the lack of oxygen.

Fortunately, by utilizing a top-quality oxygen monitor, also known as an oxygen deficiency monitor, pharmaceutical personnel can track oxygen levels and detect nitrogen leaks before an employee’s health is jeopardized.

PureAire Monitors

PureAire Monitoring Systems’ oxygen deficiency monitors continuously track levels of oxygen and will detect nitrogen leaks before the health of pharmaceutical personnel is put at risk. Built with zirconium oxide sensor cells to ensure longevity, PureAire’s O2 monitors can last, trouble-free, for over 10 years under normal operating conditions.  In the event of a nitrogen gas leak, and a decrease in oxygen to an unsafe level, the monitor will set off an alarm, complete with horns and flashing lights, alerting employees to evacuate the area.

Best practice calls for oxygen deficiency monitors to be installed anywhere there is a risk of gas leaks. The oxygen monitors should be placed wherever nitrogen is stored, and in all rooms and areas where nitrogen is used.

PureAire oxygen monitors measure oxygen 24/7, with no time-consuming maintenance or calibration required.

Each PureAire O2 monitor has an easy to read screen, which displays current oxygen levels, for at-a-glance readings by pharmaceutical manufacturing personnel, who derive peace of mind from the monitor’s presence and reliability.

Butane for THC and CBD Extraction Trend Requires Some Simple Steps to Stay Safe

On May 17^th, 2020, twelve firefighters were injured after an explosion occurred at a facility where butane is used for cannabis extraction. It is not yet known if butane was the cause of the explosion but, it was reported that, butane canisters where found in and around the building. The investigation is ongoing.

According to a Politico article, following an uptick in explosions in Colorado, fire officials there persuaded the National Fire Protection Association, which establishes a fire code for the whole country, to amend its rules to address hazards at facilities that grow and extract marijuana. The revised code requires any hazardous extraction process to be performed in a non-combustible room, in a building that contains no child or health care facilities. Staff must be trained on safe operation of the extraction equipment, and the extraction room must be equipped with a gas detection system and multiple fire extinguishing systems.

Extraction

Extraction is a process by which desired chemical compounds are extracted and separated from the cannabis plant. Extraction strips the plant of essential oils, including CBD, THC, and terpenes (aromatic oils that give cannabis plants their distinctive scents). The extracted oils can be utilized in vape pens, edibles, capsules, tinctures, and topical solutions.

Butane is one technique used to separate essential oils from the plant material. The use of butane for extraction is popular owing, in large part, to the relatively low overhead costs, efficiency (including the wide variety of products that can be created from a single extraction, without the need for further refinement), and high product quality associated with this technique. For instance, the low boiling point of butaneallow extractors to remove the desired compounds without risking evaporation of, or damage to, the delicate and heat-sensitive cannabinoids and terpenes. Moreover, the low boiling point makes it relatively easy to purge any residual butaneat the end of the extraction process, leaving behind only a relatively pure product.

Gas Detection Monitors Can Protect Extractors and Their Employees

While butane is important for extracting essential oils from cannabis plants use of this gas is not without risk, since extraction facility personnel and property are exposed to potential leaks from gas supply lines and storage containers. Butane is highly flammable and explosive gas as well.  Absent appropriate gas monitoring, an explosion can occur if butane vapors are ignited by a spark, heat, or open flame.

Proper gas detection equipment should be placed where the cannabis extraction process takes place, as well as in butane storage rooms, and in any other site where butanemay be expected to accumulate. The gas detection equipment should include the capacity to activate visual and audible alarms, stopping the flow of gas and turning on the ventilation system.

PureAire Monitors

PureAire Monitoring Systems has safety monitors to meet the needs of cannabis extractors using butane. Extractors utilizing butane rely on PureAire’s LEL, explosion-proof, combustible gas monitors. The monitor is housed in a NEMA 4 enclosure specifically designed to prevent an explosion. The durable, long-life LEL catalytic sensor will last 5+ years without needing to be replaced.

PureAire monitors feature an easy to read screen, which displays current oxygen levels for at-a-glance observation by employees, who derive peace of mind from the monitor’s presence and reliable performance. In the event of a gas leak, PureAire’s monitors will set off alarms, complete with horns and flashing lights, alerting personnel to evacuate the area. At the same time, the monitors can be programmed to turn off the flow of butaneand turn on the ventilation system.

In short, PureAire’s monitors enable cannabis extractors, in a cost-effective manner, to preserve both the quality of their products and the well-being of their employees.

 

Nitrogen Blanketing

Overview

Nitrogen (N2) blanketing is a process by which nitrogen is added to fill the headspace (the area between the fill line of a tank’s contents and the top of the storage vessel) to eliminate oxygen and moisture from storage tanks. Nitrogen is commonly used to blanket due to its extremely low reactivity with other substances, as well as its availability and relatively low cost. Other gases can also be used; however, some may be more reactive, and the costs higher,than nitrogen.

Why Blanket with Nitrogen?

Many industries, including oil, gas, and ethanol refineries, as well as chemical, pharmaceutical, and food processors, use nitrogen blanketing to prevent fires and explosions, and to preserve product quality.

Nitrogen blanketing can protect facilities from potentially catastrophic accidents when manufacturing combustibleand explosive chemicals, such as ethanol and other volatile materials, since removing oxygen eliminates the possibility of a fire and/or an explosion. Moreover, tank blanketing with nitrogen prevents oxygen, water, and other unwanted substances from coming into contact with the contents of the storage tanks, and/or causing undo wear of the tanks themselves, as oxygen and moisture inside storage tanks can cause evaporation and corrosion that may result in structural damage to the tanks.

Cooking oil processorstypically blanket with N2 to remove oxygen, which could otherwise oxidize the contents and negatively affect the tasteand,might decrease the shelf life of the oils.

Monitoring Mitigates Risks in Nitrogen Blanketing

Depending upon the needs of the facility and the type of tank, nitrogen is commonly supplied by one of the following methods: continuous purge (a constant flow of nitrogen), pressure control (N2 is added to maintain a set pressure within the tank), and concentration control.

The concentration control methodworks by using an oxygen detection monitor, in conjunction with a nitrogen generator, to continuously measure the level of oxygen inside the storage tank, and, if necessary,owing to elevated oxygen levels, add nitrogen to eliminate excess oxygen in the tank.
To ensure facility safety, protect personnel, and preserve the integrity of the tanks’ contents while blanketing with nitrogen, employees in facilities utilizing concentration control must maintain proper oxygen levels within storage tanks, as too much oxygen can cause an explosion.

Proper oxygen monitoring equipmentshould be placed inside storage tanks to measure and control oxygen levels.  Oxygen monitors should also be placed in any area where nitrogen is stored or used. Further, the O2 detection equipment should be capable of activating visual and audible alarms and, in the event of a nitrogen leak, stop the flow of nitrogen.

The same property–oxygen displacement –that makes nitrogen blanketing such a valuable process,can be deadly if nitrogen leaks from the supply lines or storage containers. Employees could suffocate from breathing oxygen-deficient air and, since N2 lacks color, and odor, there is no way, absent appropriate monitoring, to determine if there has been a leak.

PureAire Monitors

PureAire Monitoring Systems’ Explosion-Proof Oxygen Deficiency Monitor is perfect for facilities that use inert gases including, but not limited to, nitrogen, helium, and argon. The enclosure is specifically designed to prevent ignition of an explosion. The monitor is well suited for environments such as ethanol refineries, chemical manufactures, corn and grain processing facilities, powder coatingplants, and the oil and gas industry, where combustible materials, dust, and ignitable fibers are present.

The Explosion-Proof Oxygen Monitor’s built-in pump continuously samples oxygen levels from up to 100 feet away, making it ideal for use with storage tanks, confined spaces, and other hard to reach areas where oxygen monitoring is essential.

The monitor constantly measures changes in oxygen levels and can be programmed to control the flow of nitrogen as needed to ensure safe blanketing.  Additionally, should oxygen levels outside the storage tank drop to an OSHA action level,PureAire’s monitor will set off alarms, complete with horns and flashing lights, alerting personnel to evacuate the area.

The monitor will remain accurate at temperatures as low as -40C. PureAire’s durable, non-depleting, zirconium oxide sensor will last up to 10+ years in a normal environment without needing to be replaced.PureAire oxygen monitors measure oxygen 24/7, with no time-consuming maintenance or calibration required.

In short, PureAire’s Explosion-Proof Oxygen Monitor enablesoil, gas, and ethanol refineries, food processors, and other industries blanketing with nitrogen, to preserve, in a cost-effective manner, the well-being of their employees, the integrity of their products and safety of their facilities.

Overview

On January 31, 2020, the Secretary of Health and Human Services (“HHS”) declared a public health emergency related to the COVID-19 pandemic. Shortly thereafter, hand sanitizer began to disappear from U.S. retailers’ shelves, as anxious consumers (and, unfortunately, opportunistic hoarders and resellers as well) swept up all available stock. In the ensuing months, traditional hand sanitizer producers have found it impossible to keep up with the greatly elevated demand for their products, which are now considered indispensable items in efforts to control the pandemic’s spread.

Seeking to address the supply-demand imbalance currently existing within the hand sanitizer industry, the Food and Drug Administration (“FDA”) issued several industry guidance documents in March of this year (with updates later that month and in April) permitting, within specified parameters, entities not previously engaged in sanitizer manufacturing to produce, on a temporary basis (i.e., for the duration of the public health emergency declaredby the HHS Secretary in January of this year) either alcohol-based sanitizers themselves or the ethanol typically used a s a key pharmaceutical ingredient in such sanitizers.

The industry guidance documents (all of which can be found on the FDA’s website and should be read in their entirety) contemplate that such new, albeit temporary, producers of hand sanitizers (or ethanol for hand sanitizers) might include pharmacists/drug compounders and alcohol production firms (that is, distillers of alcoholic spirits for human consumption), as well as certain other businesses capable of meeting the FDA’s stringent conditions regarding hand sanitizer ingredients and manufacturing processes, as well as its registration and product listing requirements.

Since the FDA first issued its industry guidance documents in March, numerous entities and individuals have begun production of hand sanitizers (or ethanol for hand sanitizers) to address the supply gap resulting from the COVID-19 pandemic. New (albeit temporary) industry participants include manufacturing enterprises, licensed pharmacists, and distillers of alcoholic beverages. Reportedly, over 200 American distilleries (which, obviously, have deep experience in working with ethanol) have registered their facilities with the FDA pursuant to the relevant industry guidance documents.

Ethanol(a/k/a Ethyl Alcohol)

Ethanol is a clear, colorless, and (according to most people) relatively pleasant-smelling liquid made from a variety of feedstocks, including grains and crops high in sugar content, such as sorghum, corn, barley, sugar beets, and sugar cane. While it may be best known as the alcohol found in alcoholic beverages, when ethanol has been denatured (that is, made unfit for human consumption by adding certain other chemicals to it, which also make the odor unappealing), it also has many other commercial applications, including as a fuel additive, industrial solvent, key component of cosmetics and personal care items, and as the active pharmaceutical ingredient in certain disinfecting products, including hand sanitizers.

Keeping Safe While Working with Ethanol

Ethanol is highly combustible, with a low flash point, making leaks (including vapor emissions) potentially quite dangerous, and threats from accidental ignition very serious indeed. To detect, and protect against, risks emanating from leaks or excessive concentrations of ethanol, best practices include placing gas detection monitors, containing visual and audible alarms, in areas where ethanol is used or stored.

PureAireMonitors

PureAire Monitoring Systems’Combustible Gas Monitor (LEL) offers continuous readings of ethanol (and can also be programed to detectisopropyl alcohol, ethane, ethylene, and methyl alcohol). The monitor features an easy to read screen, which displays current ethanol levels for at-a-glance observation by employees, who derive peace of mind from the monitor’s presence and reliable performance. In the event of a leak or buildup of gas to an unsafe level, the monitor will set off an alarm, complete with horns and flashing lights, alerting personnel to evacuate the area. At the same time, the monitor can be programmed to turn on the ventilation system.

PureAire’s Combustible GasMonitor (LEL) is housed in a NEMA 4 explosion proof enclosure suitable for Class1, groups B, C, and D.The enclosure is specifically designed to prevent an explosion. The monitor is well suited for facilities that produce alcohol-based hand sanitizers, as well as alcohol distilleries, ethanol refineries, chemical plants, and any location where monitoring is required for combustible gases.

PureAire’s durable, long-life LEL catalytic sensor will last 5-6 years in a normal environment without needing to be replaced.

Sterilizing and Reusing N95 Respirators

Overview
Personal protection equipment (“PPE”)includes the gloves, gowns, N95 respiratory masks, and other items required by doctors, nurses, andother healthcare personnelresponsible for treating patients, including those suffering from infectious diseases.  As has become evident in the current COVID-19 emergency affecting the globe, during a crisis, these critical items may not always be available in the quantities needed to meet the challenge of treating large numbers of sick people.

Among the most sought after PPE items today are N95 respirators. According to the U.S. Food and Drug Administration (“FDA”), N95 respirators are essential gear to protect the wearer from airborne particles and to keep liquid materials from contaminating the wearer’s face. Now, more than ever, there is a need for readily available, sterile N95 respirators.

Challenge/Solution
Thus far, during the COVID-19 pandemic, we have witnessed a desperate struggle by public and private sector entities to keep up with the huge increasein N95 respirator usage which, in turn, has at times left healthcare workers and other front-line personnel without the equipment necessary to safely do their jobs. Traditionally, N95 respirators have been discarded after a single use and, while on-shore production has recently ramped up, demand for the masks far outstrips supply during the present period in which the number of COVID-19 cases surges daily.

Fortunately, as medical providers and first responders scramble to procure the safety products required to attend to the patients in their care, businesses are innovating to meet the significant challenge posed by the current respirator supply/demand mismatch.

For instance, in late March of 2020, Battelle, a Columbus, OH-based nonprofit research and development firm, received FDA approval for its Critical Care Decontamination System (“CCDS”) process for decontaminating, on a very large scale, the N95 face masks used by healthcare providers. The CCDS process involves pumping concentrated hydrogen peroxide vapor (H₂O₂) into so-called decontamination chambers (20-foot shipping containers fitted with racks on which the N95 masks are hung) for a 2 ½ hour decontamination cycle. So long as the masks have not been heavily soiled, the CCDS process will allow each N95 respirator to be sterilized and reused up to 20 times. The system is highly scalable, and Battelle, which intends to deploy CCDS as needed throughout the U.S., believes that its larger versions should be capable of sterilizing up to 80,000 N95 masks per day.

Additionally, in early April, the FDA granted STERIS, another Ohio-based company, an Emergency Use Authorization (“EUA”) to begin, on a temporary basis, small-scale N95 sterilization, pursuant to which certain of the company’s V-PRO Low Temperature Sterilization System machines are approved to sterilize up to 10 masks apiece per 28 minute vaporized hydrogen peroxide sterilization cycle. STERIS reportedly has 100 such V-PRO machines across the State of Ohio which have the capacity to sterilize N95 respirators as provided for in the EUA, and each re-sterilized mask is reusable up to 10 times by repeating the V-PRO process.

Hydrogen Peroxide Vapor
Hydrogen peroxide vapor (“H₂O₂”)is a widely used gaseous sterilant that has been shown to be effective in killing viruses, fungi, bacteria, and other pathogens, and H₂O₂ decontamination is a standard process used in pharmaceutical, research, and medical facilities.H₂O₂ vapor works by breaking apart the outer membranes of the pathogen to which it is applied, thereby destroying thedangerous microorganism.

Hydrogen peroxide is a colorless gas with a sharp odor. Exposure to H₂O₂ can irritate the eyes, nose, throat and skin, as well as cause headaches, dizziness, nausea, and vomiting. Long-term exposure can negatively affect the lungs, producing coughing and shortness of breath, and elevated levels of hydrogen peroxide may result in a build-up of fluid in the lungs (a dangerous condition known as pulmonary edema). The current OSHA permissible exposure limit (PEL) standard is 1 part of hydrogen peroxide parts per million(ppm).

Gas Detection is Crucial for Personnel Safety
Facilities using concentrated hydrogen peroxide vapor to decontaminate PPE or other medical equipment needto ensure that employees are not exposed to H₂O₂ at levels greater than OSHA’s PEL of 1ppm. Since it is always present, the odor from H₂O₂ vapor does not provide warning that hazardous H₂O₂ concentrations may exist. Therefore, in the absence of appropriate monitoring, it is impossible to determine whether hydrogen peroxide concentrations are approaching dangerous levels.

Best practices call for installation of hydrogen peroxide monitors anywhere H₂O₂ is stored or used.

PureAire Monitors

PureAire Monitoring Systems’ Universal Gas Detectors use “smart” sensor cell technology to continuously track levels of ammonia, bromine, hydrogen, hydrogen chloride, and other toxic gases, including hydrogen peroxide. The sensor cell is programmed to monitor for a specific gas and measurement range, as required by the user.

PureAire’s Universal Gas Detectors allow operators of medical decontamination facilities and systems to detect elevated hydrogen peroxide levels before employee health is put at risk. In the event that H₂O₂ is elevated to an unsafe level, the Universal Gas Detector will set off an alarm that includes horns and flashing lights, alerting staff to vacate the affected area.

The Universal Gas Detector’s easy to read screen makes it simple for employees to monitor hydrogen peroxide levels at a glance, providing them with the assurance that their health is not jeopardized while they perform their important work.